The inclusion of pregnant women in Zika virus vaccine research is crucial to solving the international health crisis, according to new guidance published this week by Institute Director and Senior Research Scholar Maggie Little and colleagues.
The KIE, the Johns Hopkins Berman Institute of Bioethics and the University of North Carolina’s UNC Center for Bioethics were awarded a £1.2 million grant from the Wellcome Trust in 2016 to develop ethical guidelines to responsibly and equitably include pregnant women in research related to public health emergencies.
“Restricting women’s access to a potentially efficacious vaccine during pregnancy is not only unethical, it’s dangerous,” says Little. “We cannot afford to exclude pregnant women from this research, because they are most affected by the virus.”
Little’s team, which includes KIE research associate Marisha Wickremsinhe, convened a 15-person working group of experts in science, health policy and research ethics from around the globe who in turn consulted with 60 leading experts in vaccine science and immunology to develop an ethical framework for including the needs and interests of pregnant women in the Zika research agenda.
The guidance centers around three moral imperatives that provide the ethical urgency for pursuing Zika virus vaccine research with pregnant women:
- Develop a Zika virus vaccine that can be responsibly and effectively used during pregnancy.
- Collect data that are specific to safety and the ability of a vaccine to effect an immune response in pregnant women to all Zika virus vaccines to which pregnant women may be exposed.
- Ensure pregnant women have fair access to participate in vaccine trials that offer a reasonably favorable ratio of research-related risks to potential benefits.